Cel The objective of “proLungPlasma” is the clinical validation of a lung cancer test, which detects DNA methylation of the specific biomarker mSHOX2. Methylation of DNA is an important epigenetic process involved in fundamental biological processes as development and cell differentiation. Aberrant DNA methylation plays a major role in cancer development. Epigenomics is very successfully engaged in epigenetic research since 1998 resulting in an outstanding proprietary platform for epigenetic biomarker discovery for cancer. Epigenomics is now market leader in epigenetic biomarker test kits detecting most frequently occurring forms of cancer as colorectal and lung cancer from different sample materials. Lung Cancer is the most deadly of all cancer diseases. Unfortunately, lung cancer screening by Low Dose Computer Tomography (LDCT) is burdened by unacceptably high false positive rates. The newly developed Epi proLung Plasma Reflex Assay is urgently required as a tool for reducing false positive rates. Therefore, the Epi proLung Plasma Reflex Assay is a highly anticipated pre-requisite for successful implementation of lung cancer screening in Europe. This business innovation project will validate the Epi proLung Plasma Reflex Assay for the diagnosis of lung cancer in plasma under the upcoming new IVD regulation. The validation process to be performed in this business innovation project will be used as a blueprint for the standardized validation of all further epigenetic biomarker blood tests. Epigenomics’ established test platform, its product development and regulatory expertise, and the standardized validation process are expected to kick-off further strong growth on major global MDx markets. Dziedzina nauki engineering and technologymedical engineeringmedical laboratory technologylaboratory samples analysis Program(-y) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Temat(-y) PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Zaproszenie do składania wniosków H2020-SMEInst-2014-2015 Zobacz inne projekty w ramach tego zaproszenia Szczegółowe działanie H2020-SMEINST-2-2014 System finansowania SME-2 - SME instrument phase 2 Koordynator EPIGENOMICS AG Wkład UE netto € 2 772 527,50 Adres KLEINE PRAESIDENTENSTR 1 10178 Berlin Niemcy Zobacz na mapie MŚP Organizacja określiła się jako MŚP (firma z sektora małych i średnich przedsiębiorstw) w czasie podpisania umowy o grant. Tak Region Berlin Berlin Berlin Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 2 772 527,50